Medical Monitor (Infectious Diseases)

PSI CRO; Madrid; Híbrido; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A leading Contract Research Organization is looking for a Medical Monitor in Spain. You will provide medical input to global clinical studies, ensuring patient safety while collaborating with various stakeholders. The ideal candidate is a Medical Doctor with at least 10 years of experience, and must possess Infectious Diseases Fellowship certification. This role offers flexibility with home-based or hybrid working options. Join a committed team fostering an inclusive culture with excellent development opportunities.

Servicios

Performance-based bonuses

Corporate benefits

Intensive induction program

Formación

• Minimum of 10 years of experience as a practicing MD required.
• Full working proficiency in English is essential.
• Proficient with MS Office applications.

Responsabilidades

• Advise on medical matters for clinical studies.
• Collaborate on preparation of clinical documents.
• Review clinical data for participant safety.
• Ensure compliance with protocols and guidelines.
• Address safety issues from site reports.

Conocimientos

Communication skills

Analytical skills

Team-oriented

Problem-solving

Educación

Medical Doctor degree

Infectious Diseases Fellowship certification

Herramientas

MS Office

Descripción del empleo

Company Description

PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.

Job Description

PSIMedical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.

Location: Home-Based or office based/hybrid in Madrid or Barcelona

Responsibilities

• Advise clients, project teams, sites, regulatory agencies and third-party vendors on medical matters
• Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
• Address safety issues across the study from sites and the study team
• Provide support to medical data review
• Participate in bid defense meetings and proposal activities
• Assist in Pharmacovigilance activities
• Identify trial risks, and create and implement mitigation strategies together with other relevant departments
• Ability to organize and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines

Qualifications

• Medical Doctor degree
• Infectious Diseases Fellowship certification is a must
• Prior and wide experience as a practicing MD (minimum of 10years)
• Full working proficiency in English
• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, team and detail-oriented

Additional Information

• Stable, privately-owned company, organically growing since 1995
• Comfortable office facilities with easy commute; opportunities to work office-based/hybrid/remote
• Intensive induction program, industry-related trainings for an optimal start and continuous development
• Friendly and supportive atmosphere in a committed team
• International environment, with colleagues around the world
• Attractive income package; performance-based bonuses; corporate benefits